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Manufacturing Associate, Cell Therapy

4 months ago


Devens, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**PURPOSE AND SCOPE OF POSITION**:
**6a-6p OR 6p-6a, with rotating weekends**

**DUTIES AND RESPONSIBILITIES**:

- Performing patient process unit operations and support operations described in standard operating procedures and batch records.
- Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
- Completing training assignments to ensure the necessary technical skills and knowledge.
- Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
- Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
- Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.
- Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

**REQUIRED COMPETENCIES**:

- High school diploma
- 0-2 years of experience in cGMP biologics cell culture manufacturing is preferred
- Bachelors in relevant science or engineering discipline is preferred e xperience
- Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations
- Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
- Must be able to work in a cleanroom environment and perform aseptic processing
- Must be comfortable being exposed to human blood components.
- Must be able to be in close proximity to strong magnets.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.

PHYSICAL DEMANDS:

- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
- Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
- Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.
- Bend and Kneel - Required to bend or kneel several times a day.
- Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
- Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
- Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

BMSCART

LI-Onsite

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider